FDA approves label addition for Stiolto Respimat (olodaterol + tiotropium) in COPD- Boehringer
The FDA approved a sNDA for Stiolto Respimat (olodaterol + tiotropium), from Boehringer, that adds data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD) to the product labelling.
The label expansion is based on data from two sets of Phase III trials—OTEMTO 1 & OTEMTO 2 and TONADO 1 & TONADO 2—from the TOviTO clinical trial program for Stiolto Respimat, which includes more than 15,000 people with varying severities of COPD worldwide. OTEMTO 1&2 were 12-week placebo-controlled trials, and TONADO 1&2 were 52-week active-controlled trials, which together evaluated Stiolto Respimat in more than 6,700 COPD patients. Data from OTEMTO 1&2 were recently published online in the journal Respiratory Medicine.
530 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.